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ACTIVE NOT RECRUITING
NCT07305350
PHASE2

EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES

Sponsor: University of Child Health Sciences and Children's Hospital, Lahore

View on ClinicalTrials.gov

Summary

To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy.

Key Details

Gender

All

Age Range

1 Hour - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-12-10

Completion Date

2026-05-10

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

DRUG

Melatonin

55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.

COMBINATION_PRODUCT

intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover

55 neonates will be assigned group B in which patients will be given standard supportive therapy only.

Locations (1)

Children Hospital and University of Child Health Sciences, Lahore

Lahore, Punjab Province, Pakistan